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Cialis multiple attempts per dose (with the exception of first few weeks treatment). The other group was placed on placebo for 12 weeks, and the study ended at end of the study, when same number of patients in each group were randomly assigned to continue the antibiotic treatment or discontinue it. The treatment groups were carefully matched with respect to medical history, medications, and other factors of interest. The patients were also given opportunity to withdraw their consent participate, and one of the clinicians involved in study (CK) told both groups to stop taking the study medication if they felt were experiencing "any worsening of my symptoms". The study's data analysis was performed by three of the researchers, including CB. Table 1: Characteristics of Patients and Study Volunteers Table 2 shows the detailed demographic and clinical information collected. All participants were male. The proportion of white participants (n=41) was slightly higher than the corresponding percentage for study's placebo group (40.1%) (χ2 1 = 13.2, P=0.004). The proportion of smokers (n=8) was slightly higher than the proportion for placebo-group participants (7.8%). Only 5.6% of experienced mild adverse events (AEs) during the study. most common AEs were upper respiratory tract infection (5.2%), diarrhea (3.9%), pain or discomfort (3.0%), and dizziness syncope (2.5%). Table 2: Characteristics Among Patients in the Two Groups The AEs did not differ between the groups with respect to age, education, and health conditions. The participants in active treatment were more likely to be younger (P=0.001); non-smokers (75.6% vs. 72.3%; χ2 2 = 9.2, P=0.02); and to have the lowest incomes (77.3% of patients in the active treatment group vs. 63.0% in the placebo-treatment group; χ2 2 = 17.9, P<0.001). Table 3 provides details on the types of patients in study. Compared with the placebo group, groups had a greater proportion of people with cardiovascular disorders in the active treatment (76.8% vs. 60.3%; χ2 2 = 2.9, P=0.039). There were also more participants who had severe asthma (P=0.005) and diabetes compared with participants in the placebo treatment. Table 3: Treatment Groups in the Two Group Study Of the 27 participants with gastrointestinal AEs during the study, 5 had GI AEs that resulted in complications. None of them was assigned to the active treatment group. However, 2 of the participants with GI AEs in the placebo-group were reassigned to active treatment group, and 1 of them completed 12 weeks treatment in the active group. addition, there were 4 participants (3 in the active treatment group and 1 in the placebo-treatment group) with gastrointestinal AEs that resulted in an episode of hospitalization or outpatient stay. All 4 participants in the active treatment were reassigned to the active treatment after 12 weeks of treatment. The primary efficacy outcome of study (the difference in the median VAS total score) and differences in change VAS total score from baseline (first treatment week) were recorded. Clinical Data Baseline Characteristics During the baseline period, 9 patients in the active treatment group and 7 patients in the placebo-treatment group were admitted to hospital (to the ED or ward), for reasons related to gastric contents or symptoms unrelated to their gastrointestinal disease. On admission, the participants were instructed by medical providers that they would be taking the study medication at home and their medical histories could be queried only to confirm their inclusion or exclusion criteria. During the study, all participants had complete and valid information on their medical histories. Medications Before the Baseline Period There were no differences in the type of medications used by participants before the baseline period (Table 4). No differences in medications were observed between the active and placebo-treatment groups on the basis of number days ingestion medications (defined as using > or =1 prescription medication). Medications During the Baseline Period.
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